COVID-19 Infection
Conditions
Keywords
Child, COVID-19 infection, immune response, healthy carrier
Brief summary
The purpose of this study is to provide data on the proportion of seroconverted children and their immune status. It will also provide insight into the number of children currently infected at each time point including healthy carriers. Investigators will provide similar data on their parents in an ancillary study.
Detailed description
The fraction of undiagnosed but likely to transmit the virus is a critical epidemiological characteristic that modulates the epidemic potential of SARS-CoV2. To adapt the epidemy control, it is essential to study the immunoprotection of the general population. A crucial question is the study of pauci or asymptomatic subjects, and in particular children who make mild forms, because they could act as a real reservoir for the spread of the virus. The serological study is essential in this context. The serologic test Abbott will be used to study immunoprevalence. Institut Pasteur has validated test using neutralizing Ab. CEA will used a antibodies and antigen test.
Interventions
BIOLOGICALserology test
volume according to child weight
BIOLOGICALnasopharyngeal swab
nasopharyngeal swab for PCR
BIOLOGICALrectal swab
rectal swab for PCR
BIOLOGICALsaliva sample
for biocollection
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Commissariat A L'energie Atomique
Institut Pasteur
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Days to No maximum
Healthy volunteers
No
Inclusion criteria
For hospitalized children or consulting at hospital * any child over 7 days old and under 17 years old in consultation or hospitalized for at most 4 days at AP-HP or CH Cayenne; Or any child over 7 days old and under 17 years old with a positive PCR at home, with an attending physician in a participating centre * Parent's agreement for blood, saliva and stool samples * Optional parent's agreement for nasopharynx swab * Optional parent's agreement for follow-up if PCR+ * With an Health insurance For children with potential COVID disease during the first wave * Any child over 7 days old and under 17 years, seropositive during the first wave * Or any child over 7 days old and under 17 years, with a previous inflammatory clinical disease potentially linked to SARS-cov2 * With an Health insurance Parent of the enrolled child * One parent of the enrolled child on ped-covid * Agreement for blood and saliva samples * Optional agreement for nasopharynx swab * Optional parent's agreement for follow-up if PCR+ * With an Health insurance For children SARS-coV2 positive * any child less then 18 years old * infected by SARS-coV2 * Parent's agreement for blood, saliva samples * Optional parent's agreement for nasopharynx swab * With health insurance For people living under the same roof of a child included in the study * any child or adult living under the same roof of a child SARS-coV2 positive and included in the study * With health insurance
Exclusion criteria
For hospitalized children or consulting at hospital * child younger than 7 days * Refusal of parent * Refusal of child * No health insurance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion against SARS-CoV2 in children | at inclusion | serology |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure of Ab antiN and Ab anti-S1/2 | at inclusion | Serology in children |
| Neutralization activity | at inclusion | Serology in children |
| Positive qPCR in children | at inclusion | in children, qualitative and quantitative measure , in nasopharynx, saliva and stool |
| correlation between different Ab and qPCR and neutralization activity | at inclusion | in children, qualitative and quantitative measure , in nasopharynx, saliva and stool, Ab anti-N, Ab anti-S1/2, neutralization serum |
| Protective immunity | Day 3 | Serology, measure of Ab in PCR positive children |
| Duration of viral carriage in stool, saliva and or nasopharynx | until 45 days if persistence of positive qPCR | Sars-Cov2 PCR in PCR positive children |
| Correlation between antibody profile and viral clearance | until 45 days post onset | Serology in PCR positive children |
| saliva biofluid characteristics of COVID-19 infected | Until 1 year follow-up | viral content (qPCR and immunodetection); presence of IgG, M, and A |
| Presence of the virus | Until 1 year follow-up | In PCR positive children: nasopharynx, saliva, stool |
| Ab profile and memory of immunity | At Day 3 | Immune cells in positive PCR children |
| Transmission of the virus to the family | until 45 days follow-up | symptomatic, virological and serological follow-up |
| Immune response | At inclusion | In children COVID+ during the first wave :immune response few months after the infection |
| Mucosal immunity | Until 1 year follow-up | In PCR positive children: Ab anti-SARS-cov2 in nasopharynx samples |
| seroconversion against SARS-CoV2 in parents | at inclusion | Ancillary study: Serology in parents |
| Measure of Ab antiN and Ab anti-S1 and neutralization activity | at inclusion | Ancillary study: Serology in parents |
| Positive qPCR in parents | at inclusion | Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva |
| Correlation between different Ab and qPCR | at inclusion | Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva, Ab anti-N, Ab anti-S1, neutralization serum |
| Saliva biofluid characteristics of COVID-19 infected | Until 1 year follow-up | in positive PCR parents: viral content (qPCR and immunodetection); presence of IgG, M, and A |
| Reinfection | Until 1 year follow-up | In PCR positive children: occurrence of reinfection, immunity responses during reinfection and potential mutations of the virus |
Countries
France
Outcome results
None listed